Medical devices are often commercially released for use with patients while new features or functions of the medical device are still under investigation due to the continuum of medical research. New functions may become available based on ongoing research or regulatory agency approval after the medical device is already in use. Since new functions may be beneficial to patients already having an existing model of the medical device, it is desirable to distribute the new functionality to these patients in a time-efficient, cost-effective manner. Manufacture and distribution of newly manufactured models including new functions is costly and timely, and may pose risk or inconvenience to the patient if the device is an implantable medical device that needs to be explanted and replaced with the new model.
Furthermore, patients may be indicated for different functions of a medical device based on their diagnostic or therapeutic needs. For example one patient may be indicated for a full function implantable cardioverter defibrillator (ICD) while another patient may only need ambulatory monitoring for arrhythmias for diagnostic purposes to determine the patient's risk for arrhythmias or need for arrhythmia therapies. The later patient would not require a more costly, full-function ICD but could be well-served by a less-costly implantable diagnostic device having limited functionality. However, manufacturing and distributing many different models of medical devices to suit varying medical needs can be costly and complicated. Furthermore, if the later patient in the above example is ultimately diagnosed as needing a full function ICD, explantation of the lower cost, diagnostic device and implantation of the full function ICD would be required, resulting in two different devices and implantation procedures being required for the same patient. For a number of reasons, therefore, there is a need to allow medical device functionality to be reconfigured post-manufacturing.